- OnDosis and Adare Pharma Solutions have entered a strategic collaboration to advance OnDosis’ lead U.S. program for an extended-release oral pellet product containing mixed amphetamine salts for ADHD treatment.
- Adare will provide CDMO services, including oral solid dosage form manufacturing and controlled-substance formulation expertise, to support development of the product for the U.S. market.
OnDosis AB, a Swedish life science company developing drug-device combinations for precision dosing of oral solid medicines, has entered a strategic collaboration with Adare Pharma Solutions. Under the agreement, Adare will provide CDMO services to support the development of OnDosis’ lead U.S. program, an extended-release oral pellet product containing mixed amphetamine salts for the treatment of ADHD.
The product is designed to be delivered through OnDosis’ Dosage Manager device platform, which enables individualized dosing. The collaboration combines OnDosis’ precision-dosing device technology with Adare’s end-to-end oral solid dosage manufacturing capabilities, including experience with controlled-substance formulations.
The companies said the collaboration will support the program’s development for the U.S. market. Adare also plans to make the precision-dosing offering available to additional clients working across different indications and markets.
OnDosis said the partnership will establish commercial-scale manufacturing capability in the U.S. The collaboration will support the program through pivotal bioequivalence studies and a subsequent 505(b)(2) submission for OnDosis’ lead product, Imfocy®, according to the company.
“We are truly excited to take this important step and establish a commercial-scale manufacturing capability on US soil through this strategic partnership with Adare. The Adare team have showed great spirit, capabilities and drive to support OnDosis in the final steps to pivotal bioequivalence (BE) studies and subsequent 505(b)(2) submission for our lead product Imfocy®, aimed at improving outcomes for patients treated for ADHD.”
Martin Olovsson, CEO and co-founder, OnDosis
